[Application of Chinese Medical Syndrome Scores in Effectiveness Evaluation: a Critical Appraisal of 240 Randomized Controlled Trials].

OBJECTIVE: To explore the role of traditional Chinese medicine (TCM) syndrome scores in effectiveness evaluation of clinical studies.

METHODS: Randomized controlled trials (RCTs) of TCM published in five journals in 2013 were retrieved, including Journal of Traditional Chinese Medicine (JTCM), Chinese Journal of Integrated Traditional and Western Medicine (CJITWM), Chinese Journal of Integrative Medicine (CJIM), Evidence-Based Complementary and Alternative Medicine (ECAM), and American Journal of Chinese Medicine (AJCM). The details of TCM syndrome scores and other relevant factors reported in articles were extracted and analyzed. Descriptive statistics and Chi-square test were used to describe general features of inclusive studies, ratios of reports on CM syndrome scores in each journal, formulated evidence, adopted evaluation rules, important degrees. The difference in the application rate of CM syndrome scores were compared in various diseases, diseases with or without CM syndrome typing, places where clinical studies were implemented, and different journals.

RESULTS: A total of 240 RCTs were included, involving 178 published in Chinese version and 62 in English version. CM syndrome scores were used for effectiveness evaluation in 27.1% (65/240) of RCTs, of which, the highest application percentage was 35.3% (18/51) in RCTs published in CJITWM, and the lowest was 0 (0/7) in RCTs published in AJCM. There were 17 methods for grading TCM syndrome scores, of which Guideline for Clinical Research of New Chinese Herbal Medicine was most commonly used. Detailed grading standards for CM syndrome scores were reported in 46 RCTs, and CM syndrome scores were taken as primary or secondary outcomes in 6 RCTs. When describing the percentages of RCTs adopting TCM syndrome score by diseases classification, the lowest was 9.5% (2/21) in mental and behavioral disorders, and the highest was 39.1% (9/23) in endocrine, nutritional, and metabolic diseases. RCTs with TCM syndrome differentiation had a higher percentage of adopting TCM syndrome score than those without TCM syndrome differentiation (P < 0.01). Statistical differences were also found among RCTs published in Chinese core journals (32.0%), domestic science citation index (SCI) journals (28.6%), and overseas SCI journals (4.9%) (χ2 = 12.4593, P < 0.01). For RCTs conducted by Chinese scholars, the percentage of using TCM syndrome score was 32.0% in three journals from China, while 7.1% in two foreign language journals, showing significant difference (χ2 =7.3615, P < 0.01); none of RCTs conducted by foreign scholars used TCM syndrome scores for effectiveness assessment.

CONCLUSIONS: There was a lack of agreeable and universal standards for TCM syndrome scores using in effectiveness evaluation. Therefore, it was not commonly used in domestic CM clinical studies. It was not so favorably agreed in overseas academic circles.